(62 days)
The dBest One-Step hCG Serum/Urine Test is a immunoassay designed for the qualitative determination of the human chorionic gonadotropin (hCG) in serum/urine for the early detection of pregnancy. It is intended for professional and laboratory use.
Not Found
The provided text includes a 510(k) premarket notification letter from the FDA regarding "dBest One-Step hCG Serum/Urine Dipstick and Cassette Pregnancy Test Kits." However, it does not contain the specific acceptance criteria or the study details that prove the device meets those criteria.
The letter primarily concerns the substantial equivalence determination for the device, allowing it to be marketed. It does not elaborate on the performance data or the methods used to establish that performance.
Therefore, I cannot provide the requested information based on the input text. To answer your questions, I would need a different document, such as a summary of safety and effectiveness, the full 510(k) submission, or a study report for the device.
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Food and Drug Administration 2098 Gaither Road Rockville MD 20850
K.C. Yee, M.D., Ph.D. · AmeriTek, Inc. 7030 35th Avenue, N.E. Seattle, Washington 98115
DEC I 7 1997
Re: K973957 dBest One-Step hCG Serum/Urine Dipstick and Cassette Preqnancy Test Kits Requlatory Class: II Product Code: JHI Dated: October 13, 1997 Received: October 16, 1997
Dear Dr. Yee:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements Please note: concerning your device in the Federal Register.
this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the requlation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Steven Litman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of Two
510(K) Number (if known): N/A
Device Name: "dBest" One Step Serum/Urine Dipstick and Cassette Pregnancy Test Kits
Indications For Use:
のあるのは、自分はないと思います。
The dBest One-Step hCG Serum/Urine Test is a immunoassay designed for the qualitative determination of the human chorionic gonadotropin (hCG) in serum/urine for the early detection of pregnancy. It is intended for professional and laboratory use.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Officer of Device Evaluation (ODE)
Prescription Use $\checkmark$
OR
over-the-counter Use
(Optional Format 1-2-96)
(Division Sign-Off)
Division of Clinical Laboratory Devios
510(k) Number. R979157
§ 862.1155 Human chorionic gonadotropin (HCG) test system.
(a)
Human chorionic gonadotropin (HCG) test system intended for the early detection of pregnancy —(1)Identification. A human chorionic gonadotropin (HCG) test system is a device intended for the early detection of pregnancy is intended to measure HCG, a placental hormone, in plasma or urine.(2)
Classification. Class II.(b)
Human chorionic gonadotropin (HCG) test system intended for any uses other than early detection of pregnancy —(1)Identification. A human chorionic goadotropin (HCG) test system is a device intended for any uses other than early detection of pregnancy (such as an aid in the diagnosis, prognosis, and management of treatment of persons with certain tumors or carcinomas) is intended to measure HCG, a placental hormone, in plasma or urine.(2)
Classification. Class III.(3)
Date PMA or notice of completion of a PDP is required. As of the enactment date of the amendments, May 28, 1976, an approval under section 515 of the act is required before the device described in paragraph (b)(1) may be commercially distributed. See § 862.3.